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MIRASOL: A Randomized Open-label Phase 3 Study of Mirvetuximab Soravtansine vs. Investigators Choice of Chemotherapy in Advanced High- Grade Epithelial Ovarian Primary Peritoneal or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

Recruiting
99 years or below
All
Phase 3
10 participants needed
1 Location

Brief description of study

The primary objective is to compare the PFS of patients randomized to MIRV vs. IC Chemo. Secondary objectives include: To compare the ORR of patients randomized to MIRV vs. IC Chemo, to compare OS of patients randomized to MIRV vs. IC Chemo, and to compare the primary patient-reported outcome (PRO) using the EORTC QLQOV28 abdominal/GI symptom scale) assessment from patients randomized to MIRV vs. IC Chemo. PFS, defined as the time from date of randomization until Investigator-assessed progressive disease (PD) or death, whichever occurs first. Results will be summarized by arm. Objective response includes best response of complete response (CR) or partial response (PR) as assessed by the Investigator.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 99 years or below
  • Gender: All
Updated on 11 Aug 2021. Study ID: 843401

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